Endoscopic procedure improves glycemia in T2D

  • van Baar ACG & al.
  • Gut
  • 22 Jul 2019

  • International Clinical Digest
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Takeaway

  • A single endoscopic intervention, duodenal mucosal resurfacing (DMR), can safely improve glycemic control over 12 months in patients with type 2 diabetes (T2D).

Why this matters

  • A minimally invasive alternative to bariatric surgery could benefit more people with T2D.

Study design

  • DMR involves catheter-based circumferential mucosal lifting followed by hydrothermal ablation of duodenal mucosa.
  • Multicenter, phase 2, open-label study of 46 patients with T2D (HbA1c, 7.5%-10.0%), and BMI 24-40 kg/m2 on stable oral glucose-lowering medication before and for ≤24 weeks post-DMR.
  • Funding: Fractyl Laboratories.

Key results

  • No unanticipated adverse device events reported.
  • In first follow-up year, 54 adverse events (AEs) deemed possibly, probably, or definitely procedure-related were reported in 24 patients in whom DMR was initiated (24/46, 52%).
  • In per-protocol population with completed DMR (n=36), HbA1c was reduced from baseline by 10 mmol/mol at 24 weeks (P<.001 preserved at months.>
  • Fasting plasma glucose was reduced by 1.7 (P<.001 and mmol at weeks months post-dmr respectively.>
  • Weight loss was −2.5 kg (P<.001 at weeks and kg months did not significantly with hba1c either time point .078 respectively>

Limitations

  • Open-label, uncontrolled.
  • Small sample size.